FDA Device recall Z-2607-2016
Radiesse (+) Lidocaine, Injectable Implant 1.5cc, Rx only, P/N: 8063M0K1, Merz Aesthetics
- FDA Device
- Class II
- terminated
- Published 2016-08-31
On 2016-08-31 the FDA classified a Class II recall of Radiesse (+) Lidocaine, Injectable Implant 1.5cc, Rx only, P/N: 8063M0K1, Merz Aesthetics by Merz North America, citing complaints reported of Radiesse (+) unable to be expelled from the syringe and/or needle.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2607-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-05-20 |
| Published | 2016-08-31 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Merz North America |
| Distribution | US |
Product
Radiesse (+) Lidocaine, Injectable Implant 1.5cc, Rx only, P/N: 8063M0K1, Merz Aesthetics. Product Usage: RADIESSE is indicated for sub-dermal implantation for the correction of moderate to severe facial wrinkles and folds.
Reason
Complaints reported of Radiesse (+) unable to be expelled from the syringe and/or needle.
Identifiers
| code_info | Model number: 8063M0K1, Lot #100088744. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2607-2016%22
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